Increasing the Accessibility of a Falls Prevention Intervention for Community Dwelling Older Adults With Low Vision

This study serves to test a previously evaluated falls prevention intervention recommended by the Centers for Disease Control and Prevention, entitled the Study of Accidental Falls in the Elderly (SAFE) Health Behavior and Exercise Intervention, to evaluate if the intervention is accessible to older adults with low vision receiving services from the Southeastern Blind Rehabilitation Center (SBRC). This study also serves to pilot a version of the SAFE intervention that has been adapted to be accessible for individuals with low vision at SBRC.

Study Overview

• Status: Completed
• Conditions: Fall; Low Vision
• Intervention / Treatment: Behavioral: Adapted SAFE Intervention; Behavioral: Original SAFE Intervention

Detailed Description

This study serves to compare the comprehension and retention of individuals completing a version of the SAFE falls prevention intervention adapted for low vision versus individuals receiving the original intervention. One group of participants will complete the standard SAFE intervention format while another group will complete the same intervention with written materials adapted for those with vision loss. One intervention (either standard or adapted SAFE program) will be delivered at a time. The SAFE intervention is comprised of four, 90-minute group classes that address environmental, behavioral, and physical falls risk factors. Classes involve lecture and group discussions as well as review of low intensity exercises. The adapted content is presented in large print with high contrast and has been rewritten on a lower grade level. A nutritionist, a physical therapist, a physician, 5 older adults with low vision, 10 low vision occupational therapist, and 5 health literacy experts provided feedback to strengthen the adapted intervention.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Department of Veteran Affairs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 60 and older;
• Visual impairment with some remaining reading ability.

Exclusion Criteria:

• Less than age 60;
• Complete blindness;
• Vertebral osteoporosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adapted SAFE Intervention; Adapted version of the SAFE Health Behavior and Exercise intervention.	Behavioral: Adapted SAFE Intervention; An adapted version of the SAFE intervention meant to target older adults with low vision.
Active Comparator: Original SAFE Intervention; Original version of the SAFE intervention.	Behavioral: Original SAFE Intervention; A CDC recommended, evidence-based falls prevention intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knowledge of falls prevention	10 multiple choice questions based on the SAFE intervention content	Pre and post (2 weeks after start of intervention delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery	Measures of balance, gait, and sit to stand	Pre
PROMIS Depression Scale	Measures depression	Pre
PROMIS Participation Scale	Measures daily participation	Pre
PROMIS Global Health	Measures general health	Pre
UAB Life-Space Inventory	Measures places travelled within past month	Pre

Collaborators and Investigators

• Sponsor: Sarah Blaylock
• Collaborators: VA Office of Research and Development
• Investigators: Principal Investigator: Cynthia Brown, MD, MSPH, Birmingham VA and UAB School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 4, 2018
• Last Update Submitted That Met QC Criteria: January 2, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Vision, Low
• Other Study ID Numbers: 01633

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All data serves to fulfill dissertation requirement and will not be shared with additional researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No